NCT02733211撤回不适用
An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes at Home
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)
研究概览
简要总结
The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their diabetes. The product automatically adjusts basal insulin delivery and delivers correction boluses in response to real-time glucose measurements by CGM to maintain blood glucose within the desired range, to improve metabolic control without increasing the risk of hypoglycemia.
The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the safety and efficacy of night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in poorly controlled patients with type 1 diabetes at home The objective of this pilot study is to evaluate the safety and efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly controlled type 1 diabetes at patient's home
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with type 1 diabetes >1year since diagnosis
- •Insulin infusion pump (CSII) therapy for at least 3 months
- •Patients able to use sensor after training based on researcher's estimation
- •Age between 10 and 18 years (both included)
- •HbA1c at inclusion between 7.5 and 11.0 % (both included)
- •Patients willing to follow study instructions
- •Patients live with at least one other adult person
- •Body Mass Index Standard Deviation Score - below the 95th percentile for age
- •Patients with caregivers who are capable of operating a computer based system
排除标准
- •Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety Participation in any other interventional study
- •Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices and planned imaging
- •Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- •Diabetic ketoacidosis in the past 1 month
- •Severe hypoglycemia six month prior to enrollment
- •Current use of the following medications: medications that are used to lower blood glucose , Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Subject is participating in another drug or device study that could affect glucose measurements or glucose management
- •Female subject who is pregnant or breast-feeding or is planning to become pregnant within the planned study duration
- •Not sufficient vision or hearing to recognize pump/sensor alarms or to perform Blood Glucose-self measurements 4-times daily.
- •Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus -Subject has unstable or rapidly progressive renal disease or is receiving dialysis-
- •Subject has active proliferating retinopathy
- •Active gastroparesis
- •Patient suffers from an eating disorder
结局指标
主要结局
Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)
时间窗: At the final visit- Day 115
次要结局
- Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l) during the night (23:00-7:00 h) and per 24 hours(At the final visit- Day 115)
- Well-Being(At the final visit- Day 115)
- Number of sensor based hypoglycemic events <60mg/d(At the final visit- Day 115)
- Percentage of glucose readings <60 mg/dl(At the final visit- Day 115)
- Area Under the Curve of sensor glucose readings >300 mg/dl(At the final visit- Day 115)
- Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours(At the final visit- Day 115)
- Percentage of glucose sensor readings above 180 mg/dl (10 mmol/l) during the night (23:00-7:00 h) and per 24 hours(At the final visit- Day 115)
- Average and standard deviation of glucose sensor readings per 24 hours(At the final visit- Day 115)
- Area under the curve of glucose readings <60(At the final visit- Day 115)
- Area Under the Curve of sensor glucose readings >240 mg/dl(At the final visit- Day 115)
- Fasting blood glucose levels(At the final visit- Day 115)
- HbA1c change from baseline to the end of the intervention period(At the final visit- Day 115)
- Diabetes-specific family conflicts(At the final visit- Day 115)
- Area under the curve of glucose readings <50(At the final visit- Day 115)
- Number of sensor based hypoglycemic events <70mg/dl(At the final visit- Day 115)
- Acceptance and use intention of an Artificial Pancreas(At the final visit- Day 115)
- Area under the curve of glucose readings <70(At the final visit- Day 115)
- Percentage of glucose readings <70 mg/dl(At the final visit- Day 115)
- Number of sensor based hypoglycemic events <50mg/d(At the final visit- Day 115)
- Percentage of sensor glucose readings >240 mg/dl(At the final visit- Day 115)
- Percentage of sensor glucose readings >300 mg/dl(At the final visit- Day 115)
研究者
研究点 (4)
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